An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Androgen-independent Prostate Cancer

Inclusion Criteria:

The following patients may be eligible for this study:

- Patients with any histologically proven prostate cancer with measurable metastatic
disease or PSA progression > 20ng/ml after initial hormonal therapy will be eligible

- Patients must be maintained on androgen ablation therapy with a LHRH agonist or have
undergone orchiectomy

- Patients in whom bicalutamide or flutamide has been recently withdrawn must
demonstrate progression of disease and be at least 6 weeks and 4 weeks respectively,
beyond the discontinuation of such agents

- Patients taking PC-SPES must discontinue therapy for a minimum of 4 weeks

- For patients with disease progression defined solely by PSA increase: two consecutive
rises in PSA measurement, over a 4-week period (each separated from the previous by 2
weeks) - the last measurement must be at least 50% greater than the nadir PSA
achieved after the last therapeutic maneuver

- For patients who discontinued bicalutamide therapy prior to study entry, a third
rising PSA measurement is required 2 weeks from the second PSA measurement (i.e. over
a 6 week period)

- Must have a life expectancy of greater than three (3) months

- Bilirubin must be within normal limits. Transaminases (SGOT and/or SGPT) may be up
to 2.5 X institutional upper limit of normal if alkaline phosphatase is less than the
upper limit of normal, or alkaline phosphatase may be up to 4 X upper limit of normal
if transaminases are less than or equal to the upper limit of normal

- For patients with disease progression defined by measurable disease: changes in
measurable size of lymph nodes or parenchymal masses on physical or radiologic
examination (bone scan findings are not adequate to assess measurable disease).

Exclusion Criteria:

The following patients are not eligible for the study:

- Patients with symptomatic CNS metastases or leptomeningeal involvement

- Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1

- Patients with severe cardiac insufficiency

- Patients taking Coumadin or other warfarin-containing agents with the exception of
low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports

- Patients who received palliative radiotherapy to tumors located centrally less than 4
weeks (28 days) prior to planned enrollment date (palliative radiotherapy to isolated
peripheral bone metastases is allowed)

- Patients experiencing hormone withdrawal syndrome, or are 28 days post-withdrawal of
anti-androgen therapy (42 days for bicalutamide)

- Patients who have had more than one prior chemotherapy regimen for hormone-resistant
metastatic disease

- Patients with disease measurable only by bone scan

- Patients who have received corticosteroids within the past 28 days (may be waived
with approval from Novartis)

- History of another malignancy within 5 years prior to study entry except curatively
treated non-melanoma skin cancer

- Patients who have undergone major surgery for any cause less than 4 weeks prior to
study entry

- Patients with radiation therapy or chemotherapy within the last four weeks

- Patients with active or suspected acute or chronic uncontrolled infection including
abcesses or fistulae

- HIV+ patients